A phase 3 study to evaluate the long-term safety, tolerability and efficacy of efgartigimod PH20 SC in adult participants with bullous pemphigoid.

An Open-label Extension Study of ARGX-113-2009 to Evaluate the Long-term Safety, Tolerability, and Efficacy of Efgartigimod PH20 SC in Adult Participants With Bullous Pemphigoid - BALLAD+

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2011230060

Enrollment

Registered

2024-03-06

Start date

2024-02-29

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bullous pemphigoid

Interventions

A loading dose at the initiation of the treatment or Day1 and Day8 of the continuous treatment, followed by weekly maintenance doses of 1000 mg will be used.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Participants can be included in the study only if all of the following criteria apply: 1. Has completed the week 36 visit of ARGX-113-2009 2. Is capable of providing signed informed consent, and complying with protocol requirements 3. Agrees to use contraceptive measures consistent with local regulations and the following: a. Male participants b. WOCBP must have a negative urine pregnancy test at baseline before receiving IMP.

Exclusion criteria

Exclusion criteria: Participants will be excluded from the study if any of the following criteria apply: 1. Clinically significant disease, recent major surgery (within 3 months of baseline), or intention to have surgery during the study: or any other medical condition that, in the investigators opinion, would confound the results of the study or put the participant at undue risk 2. Known hypersensitivity to IMP or 1 of its excipients 3. Permanently discontinued IMP in ARGX-113-2009 due to an AE considered related to IMP and for whom the benefit/risk balance is not considered positive

Design outcomes

Primary

Measure	Time frame
- Incidence and severity of treatment-emergent AEs, SAEs, and AESIs - Rate of treatment discontinuation because of safety concerns	—

Secondary

Measure	Time frame
Proportions of participants achieving: - CR while off OCS for >=8 weeks - CR or PR while off OCS for >=8 weeks - CR while on minimal OCS therapy for >=8 weeks. - CR while off both OCS and efgartigimod PH20 SC for >=8 weeks - CR or PR while off both OCS and efgartigimod PH20 SC for >=8 weeks Duration of sustained remission Proportion of participants who relapse Time to relapse Incidence and severity of relapse BPDAI activity scores, IGA-BP scores, and itch NRS over time Rate of treatment failure	—

Measure

Time frame

Proportions of participants achieving: - CR while off OCS for >=8 weeks - CR or PR while off OCS for >=8 weeks - CR while on minimal OCS therapy for >=8 weeks. - CR while off both OCS and efgartigimod PH20 SC for >=8 weeks - CR or PR while off both OCS and efgartigimod PH20 SC for >=8 weeks Duration of sustained remission Proportion of participants who relapse Time to relapse Incidence and severity of relapse BPDAI activity scores, IGA-BP scores, and itch NRS over time Rate of treatment failure

—

Countries

Australia, Bulgaria, Canada, China, Croatia, Czech Republic, France, Germany, Greece, Hungary, Israel, Italy, Japan, Latvia, Netherlands, Poland, Romania, Serbia, Slovakia, Spain, United Kingdom, United States

Contacts

Public ContactHideomi Yamaji

PPD-SNBL K.K.

hideomi.yamaji@thermofisher.com+81-90-6106-5298

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026